David M. Profile

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$17 USD / hour

arklow,

ireland

$17 USD / hour

It's currently 5:29 PM here

Joined April 6, 2018

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David M.

@davidmythen

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(0 reviews)

0.0

$17 USD / hour

arklow,

ireland

$17 USD / hour

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Mythen Corporate: GxP, Docs, Data & Web Hosting

My name is David Mythen. I am currently working in the Life Sciences Industry as Quality Assurance and I run my own consulting firm at Mythen Corporate Projects. I am very much focused on developing and growing in the Quality Assurance Industry for Pharmaceuticals as well supporting research into Business, Web Services, Clinical and Medical Device Solutions I am a two time graduate from Dubin Institute of Technology with many years experience in the clinical, pharmaceutical and web business sectors.

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Portfolio

Thesis Project & Follow On MCP Consultancy Project - Angina Monitoring Device using C++

Medical Device Design & Testing

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Experience

Merck Group

Mar 2017 - Nov 2017 (8 months, 1 day)

 Strategy & Governance – Lead local Merck anti-counterfeiting operational network teams  Incident Detection / Investigation – Proactive detection and investigation of product crime related incidents  Incident Detection / Investigation – Assist corporate security and other product crime related investigations  Networking – Function head co-ordination in support of product crime officer activities for site and corporate

Merck Group

Aug 2015 - Nov 2017 (2 years, 3 months)

Quality Assurance:  Review of API batch records and periodic review of standard operating procedures including monographs  Creation and execution of GMP related standard operating procedures, protocols and reports Validation:  Development of new site wide cleaning validation approach with integrated PDE to MACO determination Regulatory:  Development and execution of Annex 11 / part 11 based regulatory FMEA risk assessments

Mythen Corporate Projects

Jan 2009 - Aug 2015 (6 years, 7 months)

 Project Development – Multistage project development experience including research and feasibility  Regulatory Research – EU, ISO & FDA future implementation of testing and manufacture standards  Testing Research – pharmacological / toxicological evaluation of formulation and conformity  Market Research – analysis for proposal development focused on pharmaceutical and clinical areas